Pre-emptive Entry into China's 148 Million Diabetic Patient Market... Accelerating Mainland Licensing and Commercialization by Securing Real-World Data (RWD)
Signs 3-Year Non-Exclusive Distribution Agreement with Guorun... Targeting 5 Major Indications Including Diabetic Foot, Burns, and Breast Reconstruction
Two-Track Strategy Utilizing 'Early Trial and Implementation' System... 3-Year Business Plan Targets 21 Devices and 2,100 Kits

AI hyper-personalized organ regeneration platform company ROKIT Healthcare (KOSDAQ: 376900, CEO You Seok-hwan) has confirmed its entry into the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, China, and is launching its full-scale campaign into the mainland.

ROKIT Healthcare has signed a three-year, non-exclusive distribution agreement for its AI-based skin regeneration platform with Guorun, a Chinese medical enterprise. Following local administrative approval and hospital implementation procedures, the company plans to initiate its first skin regeneration surgeries on real patients at designated medical institutions in Lecheng within the next four months.

This entry is a strategic move that pre-emptively utilizes the 'Early Trial and Implementation (先行先试)' system—a special provision for the early introduction of innovative medical devices in Hainan Lecheng—to navigate the high barriers of formal approval in the Chinese medical market. Prior to official mainland licensing, the plan is to secure early Real-World Data (RWD) and key medical staff references through procedures performed on local Chinese patients.

Targeting a Serviceable Available Market (SAM) of 8.13 Million... Prioritizing Diabetic Foot

The primary areas ROKIT Healthcare is targeting in the Lecheng Pilot Zone are skin and wound regeneration indications, including diabetic foot, skin cancer excision wounds, burns, bedsores, reconstructive, and traumatic wounds. The company will supply its proprietary bioprinting system, 'Dr. INVIVO', and patient-customized AI solutions to local operating rooms.

The largest target segment is diabetic foot ulcers. According to the International Diabetes Federation (IDF) 'Diabetes Atlas 2025', China has the world's largest diabetic population at approximately 148 million. Chinese epidemiological research reports that the incidence rate of diabetic foot among diabetic patients is between 4.1% and 8.1%.

Based on Chinese and international data, ROKIT Healthcare internally estimates the Serviceable Available Market (SAM) in China across five major indications—diabetic foot, burns, breast reconstruction, post-surgery reconstruction for non-melanoma skin cancer, and bedsores—at approximately 8.13 million people. This figure reflects disease severity, the extent of skin and soft tissue defects, and the practical application scope of its regeneration technology. Among these, the diabetic foot-related market accounts for the largest share at about 6.88 million patients.

Launching a Two-Track Strategy: 'Early Clinical Trials + Mainland Licensing'

The two companies have set a primary business goal of selling and supplying 21 Dr. INVIVO devices and 2,100 regeneration kits over the next three years. Actual supply volumes will be confirmed based on future hospital adoptions and individual orders. Furthermore, performance volume is expected to expand further with the addition of designated hospitals in Lecheng and the widening of indications. The local partner, Guorun, holds a nationwide network in China and will exclusively handle the infrastructure setup for the project within the Lecheng Pilot Zone through this partnership.

Starting with this contract, ROKIT Healthcare is advancing a two-track strategy that simultaneously deploys 'securing clinical data through preemptive entry' and 'establishing a formal licensing and distribution network in mainland China'. The clinical evidence accumulated in Lecheng is expected to be utilized as foundational data in the official National Medical Products Administration (NMPA) approval process in the future.

An official from ROKIT Healthcare stated, "The entry into Lecheng is not simply about establishing a distribution hub, but an aggressive entry model to pre-emptively secure unrivaled clinical evidence through procedures on Chinese patients before mainland approval. Starting with skin and wound regeneration, we will prove the standard that leads global commercialization."